Multiple Sclerosis
Conditions
Brief summary
Multiple Sclerosis (MS) is the most common chronic neurologic disability in young adult females in their childbearing ages. Little evidence is available regarding the association between exposure to IFN-beta (β) products and adverse pregnancy outcomes. Therefore the four marketing holders of IFN-β are conducting a European-wide IFN-β pregnancy registry. Additionally, the Committee for Medicinal Products for Human Use (CHMP) has requested a study to enable identification of pregnancy outcomes in the MS population unexposed to IFN-β products for comparison with the ongoing European IFN-β Pregnancy Registry.
Detailed description
Information will be obtained from the Drugs and Pregnancy Project database (DPP - FIN) and the Medical Birth Register (MBR - SWE, NOR). The Finnish DPP and Norwegian MBR include information on all stillbirths of foetuses with a birth weight of at least 500 g or with a gestational age of at least 22+0 Gestational Week (GW). The Swedish MBR includes data on stillbirths after 28 GW The estimated number of pregnancies in MS patients needed is 1671, encompassing data from: i) FIN: 1 January 1996 - 31 December 2014; ii) SWE: 1 July 2005 - 31 December 2014; iii) NOR: 1 January 2004 - 31 December 2014.
Interventions
DRUGBetaseron (Interferon beta-1b, BAY86-5046), Bayer HealthCare AG
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)
DRUGExtavia (interferon beta-1b), Novartis Pharma AG
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)
DRUGRebif (interferon beta-1a), Merck Serono Europe Ltd
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)
DRUGPlegridy (peginterferon beta-1a), Biogen Idec Ltd
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)
DRUGAvonex (interferon beta-1a), Biogen Idec Ltd
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)
DRUGMSDMDs other than Betaseron (Interferon beta-1b, BAY86-5046)
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)
OTHERNo MSDMDs therapy (control)
Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)
Sponsors
EPID Research
Biogen
Merck Serono Europe Ltd
Novartis Pharmaceuticals
Bayer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Women who have had a pregnancy with a recorded outcome consisting of an induced abortion, spontaneous abortion, ectopic pregnancy, or birth during the study period in FIN, SWE or NOR with the event being documented in the relevant databases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the prevalence of Elective TOPFA due to different regimes of IFN-β exposure | Retrospective Data analysis: MS patients data encompassing approximately 19 years | 1. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and 2. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4) |
| Live birth while different regimes of IFN-β exposure | Retrospective Data analysis: MS patients data encompassing approximately 19 years | Cohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDs |
| MCA due to different regimes of IFN-β exposure | Retrospective Data analysis: MS patients data encompassing approximately 19 years | Cohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDs |
| Comparison of the prevalence of serious adverse pregnancy outcome due to different regimes of IFN-β exposure defined as a composite endpoint including elective TOPFA, MCA or stillbirth | Retrospective Data analysis: MS patients data encompassing approximately 19 years | 1. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and 2. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4) |
| Comparison of the prevalence of stillbirth due to different regimes of IFN-β exposure | Retrospective Data analysis: MS patients data encompassing approximately 19 years | 1. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and 2. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4) |
| Comparison of the prevalence of live birth due to different regimes of IFN-β exposure | Retrospective Data analysis: MS patients data encompassing approximately 19 years | 1. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and 2. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4) |
| Comparison of the prevalence of MCA due to different regimes of IFN-β exposure | Retrospective Data analysis: MS patients data encompassing approximately 19 years | 1. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and 2. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4) |
| Comparison of the prevalence of elective termination for other reasons than due to different regimes of IFN-β exposure | Retrospective Data analysis: MS patients data encompassing approximately 19 years | 1. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and 2. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4) |
| Serious adverse pregnancy outcome due to different regimes of IFN-β exposure defined as a composite endpoint including presence of elective Termination of Pregnancy due to Foetal Anomaly (TOPFA), Major Congenital Anomaly (MCA) or stillbirth | Retrospective Data analysis: MS patients data encompassing approximately 19 years | Cohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDs |
| Elective TOPFA for other reasons than IFN-β exposure | Retrospective Data analysis: MS patients data encompassing approximately 19 years | Cohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDs |
| Elective termination for other reasonsthan IFN-β exposure | Retrospective Data analysis: MS patients data encompassing approximately 19 years | Cohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDs |
| Stillbirth due to different regimes of IFN-β exposure | Retrospective Data analysis: MS patients data encompassing approximately 19 years | Cohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the prevalence of spontaneous abortions due to different regimes of IFN-β exposure | Retrospective Data analysis: MS patients data encompassing approximately 19 years | 1. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3), 2. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4) 3. Women with MS exposed to IFN-β regardless of exposure to other MSDMDs (cohort 2) vs. unexposed to any MSDMDs (cohort 3) |
| Prevalence of elective TOPFA stratified by specific patient characteristics | Retrospective Data analysis: MS patients data encompassing approximately 19 years | Patient characteristics: country, year of pregnancy outcome, chronic diseases, exposure to any teratogenic medications, time since MS diagnosis, duration of MS treatment, maternal age, gestational age, weight of the newborn |
| Prevalence of stillbirth stratified by specific patient characteristics | Retrospective Data analysis: MS patients data encompassing approximately 19 years | Patient characteristics: country, year of pregnancy outcome, chronic diseases, exposure to any teratogenic medications, time since MS diagnosis, duration of MS treatment, maternal age, gestational age, weight of the newborn |
| Prevalence of live birth stratified by specific patient characteristics | Retrospective Data analysis: MS patients data encompassing approximately 19 years | Patient characteristics: country, year of pregnancy outcome, chronic diseases, exposure to any teratogenic medications, time since MS diagnosis, duration of MS treatment, maternal age, gestational age, weight of the newborn |
| Prevalence of MCA stratified by specific patient characteristics | Retrospective Data analysis: MS patients data encompassing approximately 19 years | Patient characteristics: country, year of pregnancy outcome, chronic diseases, exposure to any teratogenic medications, time since MS diagnosis, duration of MS treatment, maternal age, gestational age, weight of the newborn |
| Comparison of the prevalence of ectopic pregnancies due to different regimes of IFN-β exposure | Retrospective Data analysis: MS patients data encompassing approximately 19 years | 1. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3), 2. Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4) 3. Women with MS exposed to IFN-β regardless of exposure to other MSDMDs (cohort 2) vs. unexposed to any MSDMDs (cohort 3) |
Countries
Finland
Outcome results
None listed